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Adenotonsillectomy for Pediatric Sleep Apnea

N/A
Recruiting
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pediatric OSA subjects undergoing adenotonsillectomy
Pediatric OSA subjects not undergoing treatment for the breathing condition
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial is examining the effects of sleep apnea on the brain in children.

Who is the study for?
This trial is for children aged 7-12 with moderate to severe Obstructive Sleep Apnea (OSA) who haven't had treatment yet. They'll be compared to healthy kids of the same age and body size. Kids can't join if they're obese, have had brain disorders or psychiatric diseases, cystic fibrosis, concussion, brain lesions, or any metal/electronic implants.Check my eligibility
What is being tested?
The study tests how adenotonsillectomy (surgery to remove tonsils and/or adenoids) affects brain changes, mood, and cognition in kids with OSA. It involves two visits for OSA patients: one before surgery and another six months later; controls visit once. Both groups undergo MRI scans and questionnaires.See study design
What are the potential side effects?
While not specified here, typical side effects of adenotonsillectomy may include pain, swelling in the throat area leading to difficulty swallowing or breathing problems temporarily after surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My child is having surgery to remove tonsils and adenoids due to sleep apnea.
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My child has sleep apnea but isn't currently being treated for it.
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My child is healthy.
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I am a child aged 7-12 with moderate to severe sleep apnea diagnosed by a sleep study.
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I am not taking any medications for brain disorders.
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I do not have any diagnosed neurological conditions.
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My child does not have obesity and has sleep apnea.
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I am a healthy child aged 7-12, match a child with OSA in sex and BMI, and take no brain disorder medications.
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I have not received treatment for my breathing condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Brain tissue changes between baseline and after adenotonsillectomy.
Cognition assessment after adenotonsillectomy in pediatric obstructive sleep apnea patients.
Cognitive symptoms examination after adenotonsillectomy surgery.
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: 35 Pediatric Obstructive Sleep ApneaExperimental Treatment1 Intervention
The investigators will also determine whether brain tissue changes, reduced CBF, and altered neural responses to cognitive challenge reverse, and cognition and mood signs improve after standard surgical procedure "adenotonsillectomy" for breathing condition at 6 months in pediatric OSA.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Adenotonsillectomy
2014
N/A
~820

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,525 Previous Clinical Trials
10,275,963 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total capacity of enrollees for this clinical investigation?

"Affirmative, clinicaltrials.gov states that this medical trial is actively enrolling participants. It was first uploaded on May 14th of 2022 and has since been revised as recently as June 29th. 70 individuals are sought to take part in the study at one single site."

Answered by AI

Are there any participants still needed for this experiment?

"The evidence from clinicaltrials.gov suggests that this investigation is presently recruiting patients, with the first posting occuring on May 14th 2022 and a subsequent update on June 29th 2022."

Answered by AI

Is this experiment looking to involve participants aged 45 and over?

"This trial has a lower age limit of 7, and an upper bound of 12. Consequently, minors aged between these two thresholds are eligible for enrolment."

Answered by AI

Do I qualify to participate in this experiment?

"This investigation is inviting 70 youths between seven and twelve years of age to participate. Applicants must possess a diagnosis of obstructive sleep apnea (AHI > 5 events/hour) that was received from an overnight polysomnography at a sleep centre, be without obesity (BMI ≥ 95th percentile for their respective age and gender), not yet have any treatments for the breathing condition, agree to undergo adenotonsillectomy surgery, as well as meet all criteria regarding sex, BMI-matched control subjects aged 7-12 years with no more than ±3 months' difference in age."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
UCLA
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Desperately need treatment for my sleep apnea disorder.
PatientReceived 2+ prior treatments
Recent research and studies
~3 spots leftby Apr 2024